Head of Biologics MSAT & Tech Transfer (Conjugation)

Fraser Dove International; Scotland; On-site; GBP 120,000 - 190,000; Full time

Job summary

Fraser Dove International is recruiting an experienced leader to direct technology transfer for conjugation processes entering commercial manufacturing in the UK. The role requires directing technology transfer activities across R&D, quality, regulatory and manufacturing to ensure robust, compliant processes.

You will drive scale-up, characterisation and validation studies while maintaining cGMP standards and resolving complex manufacturing issues.

Qualifications

• 10+ years of experience in biologics manufacturing or MSAT with leadership exposure.
• Proven experience transferring, scaling up and validating conjugation processes.
• Strong knowledge of aseptic techniques and regulatory requirements for biologics.

Responsibilities

• Direct technology transfer activities for conjugation manufacturing processes.
• Establish and maintain technology transfer frameworks and governance.
• Coordinate transfer activities across R&D, quality, regulatory and manufacturing.
• Review and approve transfer protocols, reports and risk assessments.
• Guide process scale-up, characterisation and validation studies.
• Ensure compliance with cGMP and global regulatory standards.

Skills

Leadership

Project management

Cross-functional collaboration

Chromatography (ÄKTA)

TFF systems

Aseptic techniques

cGMP knowledge

Regulatory understanding

Education

PhD in Biotechnology/ Biochemistry/ Pharmacy/ Chemical Engineering

Master's or Bachelor's in Biotechnology/ Biochemistry/ Pharmacy/ Chemical Engineering

Tools

ÄKTA chromatography systems

Tangential Flow Filtration (TFF) systems

Job description

Fraser Dove International is recruiting an experienced leader to direct technology transfer for conjugation processes entering commercial manufacturing in the UK. The role requires directing technology transfer activities across R&D, quality, regulatory and manufacturing to ensure robust, compliant processes.

You will drive scale-up, characterisation and validation studies while maintaining cGMP standards and resolving complex manufacturing issues.